Working closely with the QA Compliance Manager, the Quality Assurance Compliance Specialist will be instrumental in ensuring site compliance with global health authority regulations, industry standards (e.g. ISO), and organizational SOPs. They will also be key in championing and developing the organization’s Quality Mindset, Supplier Quality, Internal Audit program, support with External audits, support of Recalls and Complaints activities at INCOG, regulatory intelligence assessments, as well as annual product review. One of the key attributes for this individual would be to embrace the culture of efficiency, attention to detail, and on-time delivery. The Quality Assurance Compliance Specialist will at all times provide support with identifying and closing Operational and Quality gaps. 

The Quality Assurance Compliance Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and suppliers/partners. The Quality Assurance Compliance Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Quality Assurance Compliance Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Quality Assurance Compliance Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. 

Essential Job Functions:
• Perform primary generation and review of supplier evaluation documentation, including supplier evaluations, questionnaires, and audit reports. 
• Perform primary generation and review of supplier corrective action request (SCAR) documentation and follow through to closure.
• Perform generation and review of quality agreements between suppliers and INCOG. 
• Perform review of material specifications. 
• Perform internal audit planning and tracking of mitigations. 
• Support External/Third party audits.
• Support recalls and complaints activities.
• Support Annual Product Review activities.
• Generation and review of regulatory surveillance activities using Redica platform.
• Ability to manage multiple projects in a fast-paced environment. 
• Provide support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed. 

Job Summary